This is a double blind phase I-II clinical trial with multiple autologous T cell vaccinations
using T cell lines reactive to 9 different myelin peptides of MBP, MOG and PLP, in patients
with relapsing progressive Multiple Sclerosis.
Biological: multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides)
Biological: T cell vaccination
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Full eligibility criteria for NCT01448252
Ages eligible for Study
18 Years to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
Clinically definite MS (according to Poser's criteria) of the relapsing-progressive type (RPMS).
EDSS: 3.0 to 7.0.
Disease duration: > 1 year.
Evidence of disease progression of 1 degree in the EDSS scale, or at least two severe relapses (requiring hospitalization and treatment) during the year prior to inclusion.
MRI of the brain with at least 5 lesions in the white matter (T2 imaging).
Failure to benefit from other existing treatments according to the guidelines of the Israeli Ministry of Health.
Patients with other systemic active disease.
Patients who had been treated with immunosuppressive drugs during the 3-6 months depending on the cytotoxicity of the medication used prior to the inclusion.
Patients who previously received cellular immunotherapy or who are participating in other experimental protocols.
Pregnancy; Pregnant women or women who do not use efficacious contraception (oral contraception, or intra-uterine device).
Patients with an additional autoimmune condition unrelated to MS or significant allergy.
Patients who cannot fully understand the treatment protocol or are unable to sign the informed consent, or in whom the clinician believes that a follow-up period of at least 12 months will not be possible.
All locations for NCT01448252
Dept of Neurology,Hadassah ein-Kerem
Jerusalem, Israel, 91120
View full eligibility
Tris trial is registered with FDA with number: NCT01448252. The sponsor of the trial is Hadassah Medical Organization and it is looking for 30 volunteers for the current phase.
Official trial title: Autologous T Cell Vaccination With Line Specific for 9 Myelin Peptides in Patients With Progressive / Relapsing Multiple Sclerosis
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